Pregnenolone
Regulatory
Legal Status in 2026
No FDA-approved finished drug; permitted through 503A or 503B compounding with a prescription.
This compound is legal to prescribe and dispense through a licensed 503A or 503B compounding pharmacy with a valid prescription. It is not FDA-approved as a finished drug product, but compounding is explicitly permitted under federal law. Quality and sterility standards vary by pharmacy — look for PCAB-accredited compounders.
About
About Pregnenolone
Pregnenolone is the master precursor steroid synthesized from cholesterol and is the upstream substrate for all steroid hormones including cortisol, DHEA, progesterone, and sex hormones. It has documented neurosteroid activity and is studied for cognitive enhancement, mood stabilization, and neuroprotection. Levels decline with age and are frequently low in those with adrenal dysfunction. Available as an over-the-counter supplement.
Science
Mechanism of Action
Acts as a neurosteroid modulating NMDA and GABA-A receptors in the brain, and serves as the biochemical precursor for the entire steroidogenesis pathway — its levels influence global hormonal balance.
Dosing
Typical Protocol
10–100 mg oral once daily in the morning; best taken with food due to fat-soluble nature.
⚠ Protocol information is for educational purposes only. Dosing must be determined by a licensed physician based on individual health status and goals.
Evidence
Evidence Tier
Evidence primarily from animal studies, cell cultures, or small pilot human trials. Results are promising but have not yet been confirmed in large-scale human RCTs. Effects in humans may differ from animal models.
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